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Completed

NCT Number: NCT00318357

CARE-HF Long Term Follow-up

The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hull Royal Infirmary - Academic Cardiology Unit

Cottingham, Kingston-Upon-Hull, HU16 5JQ, United Kingdom

About this study

The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK). All patients that were reported to be alive in May 2005 will be asked to participate.

In the CARE-HF LTFU program patients from the CARE-HF trial were asked to be enrolled for an additional 4 year follow-up. Investigators were free to choose whatever available treatment they believe is in the patient's best interest, however the outcome of the CARE-HF trial suggested that all patients should receive CRT therapy on top of Optimal Medical Treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have participated in the CARE-HF program and were reported to be alive in May 2005
  • Patients who signed a patient data release consent form

Exclusion criteria

  • Patients who have not participated in the CARE-HF program
  • Patients with exclusion criteria required by local legislation

Treatment and study plan

Continuation of CRT

Device

Implantation of CRT device and medical treatment according normal hospital routine.

Other names: Resynchronisation system of the InSync® family

Upgrade to CRT

Device

Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.

Other names: Resynchronisation system of the InSync® family

Primary outcomes

  1. All Cause Mortality

    Time frame: 8-year

    Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial.

    The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-term Follow-up

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2006
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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